# K061926: Coronis 2MP and MDCG 2121 - CB

- Pathway: 510(k) (Traditional)
- Applicant: Barcoview
- Decided: Aug 18, 2006 after 42 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K001753 (2000). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052403: Coronis 2MP-21 and MFGD 2621, Barcoview (2005) Summary page 1.

## Indications for use
The MDCG 2121-CB is intended to be used in displaying and viewing digital images for review by trained medical practitioners. These devices must not be used in primary image diagnosis in mammography.

Source page: https://510kreport.com/device/K061926
Methodology: https://510kreport.com/methodology